Objective: To determine whether the risk of falling (with a possible increased chance of subdural hematoma) should influence the choice of antithrombotic therapy in elderly patients with atrial fibrillation.Design: A Markov decision analytic model was used to determine the preferred treatment strategy (no antithrombotic therapy, long-term aspirin use, or longterm warfarin use) for patients with atrial fibrillation who are 65 years of age and older, are at risk for falling, and have no other contraindications to antithrombotic therapy. Input data were obtained by systematic review of MED-LINE. Outcomes were expressed as quality-adjusted lifeyears.
The study examines the pattern of use and clinimetric properties of clinical endpoints used in randomized trials for Parkinson’s disease (PD). Randomized drug trials for PD were identified through a Medline search conducted from January 1966 until August 1998. The endpoints used in these trials were abstracted. Reports examining the clinimetric properties of the disease-specific scales used in these trials were also abstracted. Data regarding the consistency, accuracy, discrimination and feasibility of scales used in at least 10% of trials were determined. One hundred and thirty-seven articles met the inclusion criteria; 70.8% of trials used some clinical scale for PD as an endpoint. The Unified Parkinson’s Disease Rating Scale (UPDRS) was the most commonly used scale (32.8%). Factors independently associated with the use of the UPDRS included: the study location in the US, mean age of subjects over 62.7 years and publication after 1994. The UPDRS was more thoroughly studied and superior in most clinimetric domains compared to scales developed earlier. Few studies included generic health status (2.9%) or cognitive measures (16.8%) as secondary endpoints. There have been definite improvements in the area of disease-specific measurement in PD trials since the introduction of the UPDRS. The results of studies that used instruments with poor or unreported clinimetric properties should be critically interpreted.
OBJECTIVE:With respect to the use of quinine for the treatment of nocturnal leg cramps, to determine whether the findings of a previously performed meta-analysis of published data are altered with the addition of unpublished data, and whether publication bias is present in this area. DESIGN:A meta-analysis of eight (four published and four unpublished) randomized, double-blind, placebo-controlled trials, seven of which had a crossover design. SETTING:Randomized trials that were available as of July 1997. SUBJECTS:Ambulatory patients (659) who suffered from regular nocturnal leg cramps. MAIN RESULTS:When individual patient data from all crossover studies were pooled, persons had 3.60 (95% confidence interval [CI] 2.15, 5.05) fewer cramps in a 4-week period when taking quinine compared with placebo. This compared with an estimate of 8.83 fewer cramps (95% CI 4.16, 13.49) from pooling published studies alone. The corresponding relative risk reductions were 21% (95% CI 12%, 30%) and 43% (95% CI 21%, 65%), respectively. Compared with placebo, the use of quinine was associated with an increased incidence of side effects, particularly tinnitus. Publication bias is present in the reporting of the efficacy of quinine for this indication, as almost all published studies reported larger estimates of its efficacy than did unpublished studies. CONCLUSIONS:This study confirms that quinine is efficacious in the prevention of nocturnal leg cramps. However, its benefit may not be as large as reported from the pooling of published studies alone. Given the side effect profile of quinine, nonpharmacologic therapy (e.g., regular passive stretching of the affected muscle) is the best first-line treatment. For persons who find this ineffective and whose quality of life is significantly affected, a trial of quinine is warranted. Prescribing physicians must closely monitor the risks and benefits in individual patients. Publication bias is present in this area even though there is controversy about the role of quinine in the treatment of leg cramps. To minimize the possibility of this bias, persons performing medication-related meta-analyses should seek high-quality unpublished data from drug regulatory agencies and pharmaceutical companies. N octurnal leg cramps are painful involuntary muscle contractions that usually occur while the patient is recumbent. They are a common condition, occurring in 70% of elderly persons at one time or another. 1 Many nonpharmacologic and pharmacologic treatments have been proposed, 2 the most studied therapy being quinine taken at bedtime. In 1995, we published a meta-analysis examining the short-term efficacy of quinine (up to 4 weeks) for the treatment of nocturnal leg cramps. 3 The main study results combined data from four published randomized, double-blind, placebo-controlled crossover trials. [4][5][6][7] Despite review of relevant articles and textbooks, and communication with authorities on the subject, we were unable to locate any unpublished studies that met our inclusion criteria. The results ...
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.